MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD MICROTAINER® MAP K2EDTA 1.0 MG; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	363705
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using tube micro k2 edta lav map ce that there there were clotting/micro clots/fibrin clots.This occurred 10 times.The following information was provided by the initial reporter: short description: samples coagulation.When did the incident occur? after use.After sampling, some tubes show coagulation and clotting.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d4.Medical device lot #: updated to 2139564 from clarification provided by complainant.D4.Medical device expiration date: updated to 30-nov-2023 from clarification provided by complainant.D10.Device available for eval- yes.D10.Returned to manufacturer on: 04-jan-2024.H3.Device returned to manufacturer- yes.H3.Device eval by manufacturer- yes.H4.Device manufacture date: updated to 19-may-2022 from clarification provided by complainant.H.6.Investigation summary: bd had received 12 samples and 0 photos for investigation.The returned samples were tested but due to a reagent issue, the results were not conclusive.Therefore, 45 retention samples from bd inventory were visually inspected with no issues observed.Additionally, 5 retention samples were further analyzed for edta content and all were within specification.Complaints for sample quality are under statistical control for the month of august 2023.At this time, further testing is not indicated.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode clotting.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported that while using tube micro k2 edta lav map ce that there were clotting/micro clots/fibrin clots.This occurred 10 times.The following information was provided by the initial reporter: short description: samples coagulation when did the incident occur? after use after sampling, some tubes show coagulation and clotting.

• Brand Name: BD MICROTAINER® MAP K2EDTA 1.0 MG
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17555684
• Report Number: 1917413-2023-00804
• Device Sequence Number: 17053891
• Product Code: JKA
• UDI-Device Identifier: 00738743007085
• UDI-Public: 00738743007085
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 363705
• Device Lot Number: 2139564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown